FES and Upper Limb Loading Exercises Outcome Comparison on Hand Function in Spinal Cord Injury Patients (OCONHAND)

Riphah International University

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: Functional Electrical Stimulation; Other: Upper Limb Loading Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05863988

REC/LHR/23/0214 Aroosa

Details and patient eligibility

About

This study is conducted to assess the effectiveness of functional electrical stimulation Vs limb loading exercises on hand grip strength,dexterity and function in patients with subacute cervical spinal cord injury.

Full description

Spinal cord injury (SCI) is based on the concept that rehabilitative training recruits neuronal systems spinal cord injury that remain intact after the injury to take over the impaired function.Working in the field of rehabilitation of the spinal cord injured, presents many challenges. Every patient presents a new and specific challenge. The tetraplegics more so than the paraplegics as the result of loss of active function of their upper extremities in addition to loss of function in the trunk and lower extremities. This study will be conducted to assess the effects of functional electrical stimulation versus limb loading exercises on hand grip strength,dexterity and function in patients with subacute spinal cord injury.

trength,dexterity and function in patients with subacute spinal cord injury. The study will be randomized clinical trial. Participants will be randomly allocated in to two groups each group will have ten participants.. This study will be conducted in two Hospitals in Punjab pakistan. The group A Will receive functional electrical stimulation .The group B will receive upper limb loading exercises .Both groups will be given 30-45 min session 5 days per week for 8 weeks. The outcomes will be measured before and after giving treatment by using modified Action Research Arm Test (ARAT),Hand held dynamometry , Nine-Hole Peg Test (9HPT). The results will be calculated by using SPSS 23 version . Statistical tests will be applied according to the normality of the data either it will be parametric or non-parametric.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with incomplete SCI at neurological level C5-T1 in subacute stage.
• Medically stable
• Able to tolerate the Functional Electrical stimulation without sustained autonomic dysreflexia
• A score greater than 16 in mini-mental test

Exclusion criteria

• Patients taking long term steroids
• patient having pre-existing injury on upper limb or hand
• Patients have had Previous participation in experimental trial for spinal cord injury
• Patients using Currently cardioactive medications
• Individuals who has had Tendon transfers, implanted devices bladder stimulation, chronic intrathecal infusions
• Individuals with Bleeding disorders.
• Amputation of any digit on target hand

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Functional Electrical Stimulation &upper limb loading exercises

Active Comparator group

Description:

The group A Will receive functional electrical stimulation and conservative treatment 30-45 min session 5 days per week for 8 weeks.

Treatment:

Other: Functional Electrical Stimulation

Functional Electrical Stimulation & Upper Limb Loading Exercises

Active Comparator group

Description:

The group B will receive upper limb loading exercises and conservative treatment 30-45 min session 5 days per week for 8 weeks.

Treatment:

Other: Upper Limb Loading Exercises